Quality

Oscar Boscarol srl developed
its Quality system accordingly to ISO 9001 (Quality Management Systems) and ISO
13485 (Medical devices – Quality Management Systems). The company acts and
behave in compliance with all National laws besides European and local norms
(when requested) referring to medical devices design, production,
commercialization and after sale service. Particularly, the company aims to
wholly follow and respect what required by 93/42/CEE European norm, ever since
its first issue up to all revisions, modifications and later additions together
with all reference rules and guidelines in due course. Our organization has
always been involved in a process that might respect the environment and
constantly applies measures and activities aiming the utmost level of eco-sustainability. Design and homologation of our
medical devices comes from a pretty scarce compliance to customers queries and
law requirements of many devices. One of Oscar Boscarol Company first goal has
always been to design and manufacture specific products for this particular
field, continuously updated in order to satisfy both customer and legal
requests and prerequisites. The entire company organization is involved in a
process dealing with continuous improvement where the customer’s satisfaction
represents an indefeasible value.

Oscar Boscarol company has
defined its quality management system as strategic mean to:

Satisfy quality policy and its
specified goals.

Prove to be able to provide
products compliant both to our customers and legal requirements alike on a
regular basis, by efficiently applying the quality system itself.

Strengthen our tendency to
prevent and eventually correct the causes of possible problems and intervene
after the effects have been detected. Activate all procedures allowing to
prevent, intervene and document all negative effects dealing with the use of
medical devices (post-production information).

COMPANY CERTIFICATION CHRONOLOGY

93/42/CEE directive on medical
devices came into force in Italy in 1998 setting all conformity requirements
related to medical devices. Such prerequisite is mandatory by law and was
recognised by the Countries of the European Community. CE mark is one
fundamental prerequisite for the commercialization of medical devices,
accordingly to their risk class, classification and destination of use.

Vack in 1996 the Oscar
Boscarol srl got ISO 9001 certification which was achieved as a valid
instrument to improve organization, planning and the image of the company both
on international and national market places. This new quality management system
allowed the Company’s Management to establish documented processes and
procedures in order to manage all the internal activities and reach records of
penetration in the market and allowing to register nine international patents
on specific devices. The Oscar Boscarol srl has always believed in the
continuous improvement concept and thanks to its quality policy, together with
an accurate resource and strategies management oriented to the marketplace
needs has rightly achieved its place as leader in the field.

Such certification was a
peculiar step in the company growth, in fact right at the end of the year 1997
all of the devices were considered compliant to the requirements in due course,
thus complete with the CE mark.

The first certificate was
issued by the DNV, Det Norske Veritas
notify body.

SGQ revision and the
application of new norms occurred in the year 2000, well in advance with
respect to the proper effectiveness of the new norms. The certificate was obviously extended to
ISO13485:1996 auxiliary norms.

In 2003 the company Board of
directors decided it was time to change DNV notify body with the Italian IMQ in
the occasion of the extension to the new norms ISO13485:2002: this choice was
motivated by the research of an Italian notify body which also had a laboratory
on its own, aiming to reduce management global expenses besides the products
homologation cost.

In 2005, after the new self-referring
norm came into force, the Company successfully passed the audit for the
certification issue, thus becoming one of the few Italian companies having
reached this goal well in advance.

In December 2007 the notify
body was changed again to TÜV SÜD Product Service GmbH, by which the Company is
currently certified.

Since aSeptember 2009, after
the renewal audit performed by the TÜV SÜD Product Service GmbH notify body,
the Oscar Boscarol company is certified accordingly to the newISO9001:2008.